Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
1期
已完成
NCT01865552
| 适应症 | Healthy |
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| 分期 | 1期 |
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| 申办方 | Samsung Bioepis Co., Ltd. |
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| 状态 | 已完成 |
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| 受试者人数 | 138 人 |
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| 干预（药物） | SB4, EU sourced Enbrel, US sourced Enbrel |
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| 开始日期 | 2013年5月 |
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| 完成日期 | 2013年8月 |
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| 结果公布日 | 2019年6月4日 |
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摘要
The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
0 to 480 hours post-dose · µg·h/mL
| SB4 in Part A | 769.069 ± 243.9039 µg·h/mL |
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| EU Sourced Enbrel in Part A | 771.680 ± 226.2874 µg·h/mL |
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| SB4 in Part B | 834.680 ± 242.7652 µg·h/mL |
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| US Sourced Enbrel in Part B | 810.054 ± 195.9770 µg·h/mL |
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| EU Sourced Enbrel in Part C | 790.110 ± 274.2535 µg·h/mL |
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| US Sourced Enbrel in Part C | 768.228 ± 238.1251 µg·h/mL |
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Maximum Serum Concentration (Cmax)
0 to 480 hours post-dose · μg/mL
| SB4 in Part A | 3.607 ± 1.4298 μg/mL |
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| EU Sourced Enbrel in Part A | 3.435 ± 1.2390 μg/mL |
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| SB4 in Part B | 3.869 ± 1.3251 μg/mL |
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| US Sourced Enbrel in Part B | 3.613 ± 1.0252 μg/mL |
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| EU Sourced Enbrel in Part C | 3.720 ± 1.5444 μg/mL |
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| US Sourced Enbrel in Part C | 3.575 ± 1.4833 μg/mL |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。